Lyumjev (insulin lispro-aabc injection) / Eli Lilly - LARVOL DELTA

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=150 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed | N=112 ➔ 150

Enrollment change • Trial completion • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Stanford University

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Nano-Amounts of Glucagon Premixed With Fast-Acting Insulin Lispro: Effect on Insulin Absorption in Pigs. (PubMed, Curr Ther Res Clin Exp) - "Nine pigs were included in the control groups; they received a subcutaneous injection of 10 U of insulin lispro (LyumjevⓇ or HumalogⓇ). A similar trend was observed when HumalogⓇ/glucagon was injected (306 mU×min/L vs 65 mU×min/L, SE = 125), although this difference did not reach statistical significance (P = 0.102) compared with the control groups. This series of proof-of-concept experiments in anesthetized pigs indicate that premixing nanogram doses of glucagon in fast-acting insulin lispro formulations may speed up the absorption of subcutaneously injected insulin."

Journal • Anesthesia

Efficacy of Ultra-rapid and Rapid-Acting Insulin Analogs in Hybrid and Advanced Automated Insulin Delivery Systems among People with Type 1 Diabetes—A Systematic Review and Meta-analysis of Randomized Controlled Trials (ADA 2025) - "Inclusion criteria were RCTs; T1D populations of any age; comparing URIAs (Fiasp® or Lyumjev®) with any type of RIAs; using any type of AID systems. URIAs safely improved glycemia and were comparable to RIAs among T1D people using AID systems. Despite outcomes demonstrating statistical significance, the clinical impact may be small, given the TIR improvement of 1.4% (registration ID: CRD42024578754)."

Metastases • Retrospective data • Review • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

MicroGlucag2: Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=30 | Suspended | Sponsor: St. Olavs Hospital | Not yet recruiting ➔ Suspended | Trial primary completion date: Jul 2025 ➔ Nov 2025

Trial primary completion date • Trial suspension • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR

New trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

MICRO-AMOUNTS OF GLUCAGON PREMIXED IN FAST-ACTING INSULIN (LYUMJEV®); EFFECT ON INSULIN ABSORPTION AND GLUCOSE CONSUMPTION (ATTD 2025) - "We expect to observe that premixing ng amounts of glucagon added to a fast-acting insulin speed up insulin absorption also in patients with T1D and enhances the effect on glucose metabolism. That will be a major achievement that potentially will benefit all patients with T1D. And it may make a fully automated artificial pancreas possible."

Anesthesia

FIRST CLINICAL REPORT OF THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM BOLUS CALCULATOR USE IN FREE LIVING ENVIRONMENT (ATTD 2025) - "The Lilly Tempo Smart Button enables Basaglar®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. Use of the IC was consistent across all meals and corrections.Conclusions The aggregate glucose data indicates increased usage of the IC over the 6-week period corresponds to greater trust in the IC recommendations, as a significant percentage of administered doses were within 10% of the IC's suggested dose. Aggregate data indicates meaningful improvement in glycemic outcomes with the Tempo Platform IC over this period."

Clinical • Diabetes • Metabolic Disorders

MicroGlucag2: Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: St. Olavs Hospital

New P1/2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Investigation of Severe Hypoglycemia Risk Among Patients with Diabetes Treated with Ultra-Rapid Lispro in Japan. (PubMed, Adv Ther) - "This study did not show a statistically significant increase in the incidence and risk of the first severe hypoglycemia event requiring a hospital visit in real-world URLi-treated patients in Japan, compared with a PS-matched cohort of other RAIA-treated patients."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the Cambridge Hybrid Closed-Loop System for Individuals With Type 1 Diabetes. (PubMed, J Diabetes Sci Technol) - "There were no safety issues when using Boost and Ease-off with ultra-rapid insulins. The use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

TLV-0332-24: Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Tel-Aviv Sourasky Medical Center

New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Glycemic Outcomes with Rapid Insulin vs. Ultrarapid Insulin in Omnipod 5 (OP5) (ADA 2024) - "Ultrarapid insulins (Lyumjev, Fiasp) are designed to reduce post-prandial excursions and may be beneficial in automated pumps. However, satisfaction and bolus overrides improved with ultrarapid insulin. A larger sample size and meal-specific measures are needed to connect patient experience with glycemic outcomes."

Diabetes • Metabolic Disorders

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Multicenter Evaluation of Ultra-Rapid Lispro (URLi) Insulin with Control-IQ Technology in Adults, Adolescents and Children with Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - "URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with type 1 diabetes, with quality of life benefits of URLi use perceived by the study participants."

Journal • Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P4 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Lilly-MEALS: A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

FROM CLINICAL DATA TO CLINICAL INSIGHTS – TRANSFORMATIVE OPPORTUNITIES FOR CLINICAL CARE USING THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM: A CLINICAL TUTORIAL (ATTD 2024) - "The Lilly Tempo Smart Button™ enables Basaglar ®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. The Tempo system can provide the missing information to the HCPs to transform the guess work and difficult conversations with PwDs to an opportunity for personalized and precision medical advice and better experience to the PwDs and the HCPs."

Clinical data • Diabetes • Metabolic Disorders

EXERCISE INCREASES CIRCULATING INSULIN LISPRO CONCENTRATIONS IN ADULTS WITH TYPE 1 DIABETES ON PUMP THERAPY THAT IS ATTENUATED BY SWITCHING TO ULTRA-RAPID INSULIN LISPRO (URLI) (ATTD 2024) - "The efficacy of performing a 50% BRR 1-hr before exercise with Lispro in CSIIOL is limited by an activity-associated increase in insulin absorption rate that is partially overcome with URLi."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

SAFETY AND PERFORMANCE OF AN ADVANCED HYBRID CLOSED‐LOOP ALGORITHM WITH ULTRA RAPID LISPRO AND LISPRO (ATTD 2024) - "Results suggest reduced hypoglycaemia with URLi vs Lispro with comparable glycaemic control. The AHCL algorithm showed promising glycaemic performance in a supervised setting when used with URLi or Lispro."

Clinical • Metastases • Severe Hypoglycemia

EFFECTS OF MICRO-DOSE GLUCAGON ON SUBCUTANEOUS INSULIN ABSORPTION IN PIGS (ATTD 2024) - "Adding glucagon to Lyumjev® further enhances insulin absorption and the insulin effect on glucose metabolism. This increased insulin absorption may make a fully automated artificial pancreas possible. Further experiments on premixing glucagon and insulin and repeating glucagon injections are ongoing and will also be presented."

Anesthesia